EP3916346B1 - Verfahren zur herstellung von massgeschneiderten einlagen - Google Patents

Verfahren zur herstellung von massgeschneiderten einlagen Download PDF

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Publication number
EP3916346B1
EP3916346B1 EP20211067.2A EP20211067A EP3916346B1 EP 3916346 B1 EP3916346 B1 EP 3916346B1 EP 20211067 A EP20211067 A EP 20211067A EP 3916346 B1 EP3916346 B1 EP 3916346B1
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EP
European Patent Office
Prior art keywords
foot
insole
acquisition device
orthotic
point
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EP20211067.2A
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English (en)
French (fr)
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EP3916346A1 (de
Inventor
Raffaele Ferrante
Marco Mannisi
Daniele Bianchi
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Medere Srl
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Medere Srl
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01B—MEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
    • G01B11/00—Measuring arrangements characterised by the use of optical techniques
    • G01B11/24—Measuring arrangements characterised by the use of optical techniques for measuring contours or curvatures
    • A—HUMAN NECESSITIES
    • A43—FOOTWEAR
    • A43B—CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B17/00—Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined
    • A43B17/14—Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined made of sponge, rubber, or plastic materials
    • A—HUMAN NECESSITIES
    • A43—FOOTWEAR
    • A43B—CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00—Footwear with health or hygienic arrangements
    • A43B7/14—Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405—Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/141—Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form having an anatomical or curved form
    • A—HUMAN NECESSITIES
    • A43—FOOTWEAR
    • A43D—MACHINES, TOOLS, EQUIPMENT OR METHODS FOR MANUFACTURING OR REPAIRING FOOTWEAR
    • A43D1/00—Foot or last measuring devices; Measuring devices for shoe parts
    • A43D1/02—Foot-measuring devices
    • A43D1/025—Foot-measuring devices comprising optical means, e.g. mirrors, photo-electric cells, for measuring or inspecting feet
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y50/00—Data acquisition or data processing for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • A—HUMAN NECESSITIES
    • A43—FOOTWEAR
    • A43D—MACHINES, TOOLS, EQUIPMENT OR METHODS FOR MANUFACTURING OR REPAIRING FOOTWEAR
    • A43D2200/00—Machines or methods characterised by special features
    • A43D2200/60—Computer aided manufacture of footwear, e.g. CAD or CAM
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing

Definitions

  • This invention relates to a method for the production of customised orthotics.
  • the invention relates to a method for the production of orthotics in which clinical and biometric data can be integrated.
  • orthotic may be replaced by the expression “orthotic insole” or “insole”.
  • orthopaedic orthotics footwear and aids is one of the most widespread solutions in the rehabilitation and pain management sector.
  • Many musculoskeletal diseases are in fact associated with postural problems in the lower limbs.
  • Orthotics are therefore an optimum solution for the postural adaptation of the foot with the aim of making structural changes extending to the rachis and cervical area.
  • the invention refers to the above-mentioned technological innovations applied in the field of the production of orthotic insoles.
  • patent document US 2016 110 479 A1 describes a semi-automatic method for the production of an orthotic insole, in which a digital model of the insole is discretized, for the creation of a grid-type model which defines the upper surface of the orthotic insole.
  • this method has high computational costs.
  • patent document US 2016 110 479 A1 uses this grid-type discretization, the final model of the orthotic insole may be affected by errors such as, for example, an incorrect modelling due to a small number of elements.
  • this method is highly dependent on the choice of the dimensions and proportions of the rectangular elements, which must be sufficiently small to guarantee an accurate model which is able to meet the needs of the individual foot.
  • patent document US 2016 110 479 A1 comprises a final phase wherein the reconstructed orthotic insole can be modified on the basis of any medical prescriptions or specific needs of the patient.
  • the method described in patent document US 2016 110 479 has long modelling times and does not allow an active control over the final result of the orthotic insole during the modelling step, nor does it ensure the effectiveness of the modification made.
  • making changes at a later date could lead to a modification of the structure and surfaces of the orthotic which were not foreseen at the initial step.
  • this method offers limited freedom of choice on the part of the technician responsible for controlling the final shape.
  • the method according to the invention aims to define a standard dataset for the production of customised orthotics.
  • the aim of the invention is therefore to define a standardised method for the production of corrective and/or sports orthotics which is as independent as possible from the podiatry problem which is to be solved.
  • a further aim of the invention is to improve the quality of the orthotic insole produced, in terms of patient comfort, compared to prior art devices.
  • the aim of the invention is to provide an automatic or semi-automatic method which is easy to implement, robust and reliable and with low computational costs.
  • an aim of the invention is to provide a method which can be applied to the production of both corrective and sports insole orthotics.
  • an aim of the invention is to allow the production of insole orthotics at a low cost, when compared to the prior art technique.
  • the method according to the invention aims to produce customised corrective and/or sports orthotic insoles as follows:
  • the method is aimed at the production of orthotic insoles and provides, as a first step, a protocol for the acquisition of the image and/or video datasets through the use of a generic electronic device equipped with a camera (for example, smartphone, tablet).
  • the protocol will guide the positioning of the acquisition device and parts of the body with the aim of acquiring optimised photographic images and videos for the production of the orthotic insoles.
  • the protocol may also provide for the use of particular clothing (for example socks, stockings, bands) which facilitate the recognition of specific anatomical characteristics of the foot.
  • the videos and images collected allow the three-dimensional CAD reconstruction of the foot.
  • the reconstruction can be performed using different technologies such as, for example, photogrammetry and/or mesh morphing.
  • a method of modelling comprises the definition of fundamental lines and points starting from the geometric information of the reconstructed foot and the photographic images acquired, for modelling a digital model of an orthotic, also called a virtual orthotic.
  • the modelling method can integrate clinical data such as, for example, baropodometric data, force distribution, centre of mass position, MRI, CT, gait analysis.
  • clinical data such as, for example, baropodometric data, force distribution, centre of mass position, MRI, CT, gait analysis.
  • the integration of such clinical data may comprise the use of artificial intelligence algorithms.
  • the digital model of the orthotic can be produced using modern 3D printing technology.
  • the production method developed may comprise the modification of one or more manufacturing parameters (for example, material, material shore hardness rating, infill shape, infill thickness) in specific regions.
  • the object of the invention is therefore a method for the production of customised corrective and/or sports orthotic insoles as defined in claim 1 as well as a system configured for executing said method as defined in claim 12, a computer program comprising instructions for executing said method as defined in claim 14 and a data carrier signal that carries the instructions of said program as defined in claim 15.
  • the method may also comprise the characteristics defined in dependent Claims 2 to 11.
  • a method according to the invention comprises:
  • the proposed method allows, advantageously, a digital model 100 to be obtained which is accurate compared to prior art models, being able to be made on the basis of the reconstructed geometry of the foot F'; F", obtained through digital acquisitions.
  • the modelling phase can use points and lines selected on the basis of anatomical reference points and construction lines, which divide the plantar area of the foot F'; F" into areas of high medical importance, also called anatomical areas of interest.
  • the method according to the invention may also include a final step of production of the modelled orthotic insole 1.
  • the method according to the invention can be performed completely locally, for example via a mobile device app comprising a video camera, in particular a smartphone or tablet.
  • a mobile device app comprising a video camera, in particular a smartphone or tablet.
  • the smartphone or tablet can also be configured to send the final model to a 3D printer.
  • the acquisition step can be performed by means of the acquisition device, which can be configured to acquire said datasets of the feet F'; F" and send them to a remote server control unit, configured to perform said modelling step.
  • a remote server control unit configured to perform said modelling step.
  • an app on a mobile device can be configured to perform the acquisition step, allowing the user to check the acquired datasets and have them sent to said external server using the appropriate button.
  • this external server can be the external server of an e-commerce site which allows footwear to be purchased comprising customised orthotic insoles.
  • the acquisition protocol may comprise the acquisition of a video per foot F', F" of the user, by means of a special acquisition device C.
  • the acquired videos can in fact form a fundamental part of the initial dataset for the subsequent modelling and production of the orthotic insole 1, as illustrated below.
  • the acquisition protocol may also require that the foot F', F" and the acquisition device C are arranged in specific positions, for example in such a way as to comply with instructions I1 to I10 described below.
  • the acquisition protocol can comprise the acquisition of six F1-F6 photographic images of the feet F'; F" in total. More in detail, these photographic images F1-F6 can be acquired by following the instructions described below.
  • the acquisition protocol may comprise the use of special clothing, such as socks, stockings, bands or meshes (not shown).
  • the acquisition protocol shown in Figures 1 - 5 comprises the acquisition of a total of 2 videos and 6 images.
  • the acquisition protocol can comprise a series of instructions designed to optimise the next step of digital reconstruction of the geometry of the foot.
  • the instructions I1-I10 for the acquisition of the videos, discussing their advantages, are given below.
  • the instructions I1-I10 are:
  • the acquired video will be between 30 and 40 seconds long.
  • the instructions 15-110 can be carried out by a second person (as shown in Figure 1 ).
  • instructions I1 and I2 have been specially studied to allow said second person to comfortably and easily carry out the subsequent instructions 15-110 of the protocol.
  • the instructions I3 and I4 have been specifically studied to position the foot in the optimal anatomical position for the subsequent design of the corrective and/or sports orthotic insole. In fact, the indicated position allows the recognition of salient points and lines which will be defined later in the description of the design.
  • the instructions I1 - I4 allow you to capture each foot F', F" with the plantar fascia under maximum tension.
  • the positioning of the ankle at 90° and the maximum extension of the toes results in maximum tension of the plantar fascia.
  • This allows the foot to be divided into different zones (medial, central and lateral) and to model the orthotic on the basis of this additional information.
  • the full extension of the toes causes the tension of the soft tissue and reduces the possible artifact caused by the soft tissue itself.
  • the complete extension therefore makes the subsequent 3D reconstruction of the foot and the identification of the fundamental anatomical points PAF1-PAF3 which will be described below more accurate.
  • the instructions 15, I6 and I7 have been specially studied to optimise the video for three-dimensional reconstruction using photogrammetry algorithms.
  • the supposing or overlay area defined in I5 has an ellipsoidal shape and is centred with respect to the acquisition area (as shown in Figure 1 ).
  • the ellipse has a major axis with measurement AM whilst the minor axis has preferably a measurement equal to AM*3/4.
  • the AM size can be defined on the basis of the acquisition device C for the video acquisition.
  • the instructions I8 and I9 ensure that the geometric information of the sole of the foot F'; F" and heel is obtained. In fact, the position of the acquisition device C in line with the foot allows the morphology of the heel to be acquired, whilst the prescribed movement around the foot allows the geometric information of the sole of the foot to be obtained. These instructions therefore ensure that the necessary morphological information is obtained for the correct reconstruction of the geometry of each foot and the subsequent prototyping of the corrective and/or sports orthotic insole.
  • the instruction I10 ensures that the video is of sufficient quality to extract the necessary information.
  • the indicated rotation speed has been defined to ensure that the extrapolated frames have sufficient sharpness of the edges of the geometry of the foot (approximately 2 Ip/mm).
  • artificial intelligence algorithms may be used to increase the sharpness.
  • VDSR Very-Deep Super-Resolution
  • the illustrated acquisition protocol provides for the acquisition of a series of six photographic images F1-F6 designed to optimise the step for reconstruction of the geometries of the foot F' or F" and to model the corrective and/or sports orthotic insole 100 according to the specific needs.
  • the instructions for following the protocol developed and the functionalities of each individual photo are described below.
  • the instructions for acquiring the photographic images F1-F6 are as follows:
  • the photographic images F1 and F2 guarantee that the shape of the right foot F' and left foot F", respectively, under the load of the body is obtained.
  • the photographic images F1 and F6 make it possible to outline the morphology of the plantar arch during one of the crucial phases of walking, namely the monopodal support phase. This information makes it possible to assess any deformities which occur under load which may cause illness or pain.
  • the indicated framing also makes it possible to evaluate the trend of the longitudinal medial arch and its response to body weight. In this way it is possible to observe any pronation or supination of the foot.
  • the photographic images F1 and F2 of the right foot F' and left foot F" allow an assessment to be made of any structural failure of the feet F' or F" under load.
  • the medial view in monopodal support shows the adaptation of the foot F' or F" in the phase of maximum body weight support, it thus being possible to assess the variation of the articular and bone structures during one of the fundamental phases of walking.
  • photographic images F1 and F2 also make it possible to assess the angle of the longitudinal medial arch, as well as the "index of the height of the medial arch", which are important measurements for assessing and differentiating a flat foot from a normal foot or a hollow foot.
  • the photographic images F3 and F4 guarantee that the shape of the right foot and left foot is obtained during the final phase of the walking.
  • the photo shown will allow an assessment to be made of the "toe-off" phase (that is, end of cycle) wherein the foot is about to detach from the ground to start the swinging phase leading to the next step.
  • This frame makes it possible to assess the shape that the foot adopts during this last phase of pushing against the ground and to perceive any deformities or alterations in the walk.
  • Photo F5 makes it possible to assess any asymmetries as well as failure of the longitudinal plantar vaults. In fact, by keeping the feet with the heels together and the toes separated, there is an equal distribution of weight between the two feet. In this way it is possible to compare whether the failure or deformity of a foot F' or F" is present to the same extent in the contralateral foot F' or F". Moreover, there is a good view of the ankle joint.
  • the photo F5 of the feet F' and F" allows an assessment to be made of whether there is any dissymmetry between right and left side under equidistributed load.
  • this representation makes it possible to observe any differences in the failure of the plantar arch or of the articular structure seen medially. From this image it is therefore possible to understand how to intervene in the subsequent phases of modelling and making the orthotic in order to correct any dissymmetry.
  • Photo F6 is used to assess the rear alignment of the foot with respect to the leg. In this frame, it is possible to assess the alignment of the calcaneare in a neutral position and with an equal distribution of weight between the two feet. From this analysis it is possible to estimate valgus or varus deformity of the articulation itself and to evaluate possible corrections.
  • the photo F6 of the feet F' and F makes it possible to assess the rear alignment of the joints, also known as the "rearfoot angle”.
  • This parameter is used to quantify the degree of pronation or supination of the foot. Its importance and validity has been demonstrated in numerous clinical and scientific studies and is one of the most widely used measurements in the sector. From this information it is possible to classify the foot in various connotations.
  • the images F1-F6 and the videos obtained from the acquisition protocols described allow a dataset to be obtained comprising photographic images of the feet with sufficient information to reconstruct the three-dimensional geometry of a foot F' or F" and to integrate personalised information of the foot F' or F" in the next modelling and prototyping strep of the digital model 100 of the orthotic insole 1.
  • the reconstruction can be carried out by using photogrammetry algorithms developed ad hoc or commercial photogrammetry software.
  • a sequence of frames can be calculated from the acquired video, in order to obtain an overlapping (that is, the percentage of image in a photograph related to a region of the space also taken from a nearby photograph) of 80%.
  • the reconstruction may include an optimisation step of the reconstructed mesh.
  • the solid obtained can then be optimised thanks to mesh morphing algorithms, using the sequence of frames obtained from the video.
  • radial basis type functions for mesh morphing (that is, based on the distance between the points) can be used so that the position of the points identifying the characteristics of the sole of the foot in the frames coincides with the corresponding points of the reconstructed solid.
  • a three-dimensional geometry of the foot F' or F" can be acquired directly by means of the acquisition device C, for example a 3D scanner or a smartphone equipped with a time-of-flight (ToF) sensor.
  • the acquisition protocol may comprise only the acquisition of the photographic images F1-F6 and not the instructions 11-110.
  • This modelling phase can be semi-automatic, under the supervision of an operator or technician, or it can be fully automated, using specially trained machine learning algorithms.
  • the modelling phase may comprise the definition of the fundamental anatomical points PAF1-PAF3 and anatomical lines L1-L3, CM on the reconstructed model of the foot F' or F" and/or the digital model 100 of the insole.
  • curves C1-C7 and points P1-P7 will be defined on said digital model 100 of the insole to be modelled.
  • the construction parameters of the curves C1-C7 and the coordinates of the points P1-P7 may vary by 10% with respect to the instructions specified below.
  • User-specific clinical data can be integrated in this modelling step, such as, by way of example only, baropodometric data, force distribution, centre of mass position, MRI, CT, gait analysis.
  • the digital model 100 can be available on an e-commerce server, as described above, wherein footwear complete with the customised orthotic insole 1 is sold, modelled by means of the method according to the invention starting from the native insole of the footwear itself.
  • the datasets acquired during the acquisition step can be uploaded to the server, and the modelling step can take place directly on the server before or after the purchase of the footwear.
  • the native digital model 100 of the insole of the footwear on the basis of which the orthotic insole 1 is to be modelled, can be downloaded from the server to the mobile acquisition device or other local device configured to perform the modelling step, and the final digital model 100 of the orthotic insole 1 modelled by means of CAD modelling can subsequently be sent to the e-commerce service for its production and delivery to the customer.
  • the user may request the modelling of an orthotic insole 1 for ankle boots with a heel, and the modelling step will be carried out starting from a standard digital insole model 100 for this type of footwear.
  • a first step of the modelling comprises dimensioning the external boundary of the digital model 100 of the insole based on user/customer information.
  • the reconstructed model of the foot F' is positioned on the digital model 100 of the insole. This positioning starts from the identification of fundamental anatomical points PAF1-PAF4 on the reconstructed model of the foot F'.
  • the centre of the heel PAF1 the base of the first metatarsus PAF2, the base of the second metatarsus PAF3 and the base of the fifth metatarsus PAF4.
  • Figure 6 shows the points PAF1-PAF4 on a reconstructed model of the foot F' and the positioning of this reconstructed model on the digital model 100 of the insole.
  • Figure 6 shows the reconstructed geometry of a right foot F' aligned on a digital model 100 of the insole.
  • the alignment of the reconstructed model of foot F' on the digital model 100 of the insole is carried out in the following way.
  • the reconstructed model of the foot F' or F" is initially positioned in a neutral position, with the points PAF1, PAF2 and PAF4 lying on the same plane. Starting from this neutral position, it is possible to rotate and incline the reconstructed model of the foot F' or F" in order to position it in the appropriate position for a necessary corrective need.
  • a technician may be able to manually modify parameters such as intra/extra rotation of the rear portion of the reconstructed model of the foot F'; F" directly during this step and not as a subsequent action.
  • This offers an advantage in terms of active control over the final result and the corrective effectiveness of the final orthotic insole 1.
  • the fact that a technician can use all the data collected since the beginning of modelling can make the final product more accurate.
  • the next step comprises the definition of anatomical lines of interest L1, L2, L3 on the digital model 100 of the insole and, consequently, of relative anatomical areas of interest.
  • three anatomical lines of interest L1, L2, L3 are drawn on the digital model 100 of the insole, corresponding to the projections of the connecting lines, respectively, between the centre of the heel and the base of the first metatarsus, between the centre of the heel and the base of the second metatarsus and between the centre of the heel and the base of the fifth metatarsus.
  • a third degree curve CM is also drawn, also called the support curve CM, passing through the three points which identify the base of the first, second and fifth metatarsus.
  • Figure 7 shows the three anatomical lines of interest L1, L2, L3 and the support curve CM just defined on said digital model 100 of the insole.
  • a first line of interest L1 relative to the connecting line between the centre of the heel and the base of the first metatarsus of the reconstructed model of the foot F'
  • a second line of interest L2 relative to the connecting line between the centre of the heel and the base of the second metatarsus of the reconstructed model of the foot F'
  • a third line of interest L3 relative to the connecting line between the centre of the heel and the base of the fifth metatarsus of the reconstructed model of foot F'
  • the first anatomical line of interest L1 passing between the base of the first metatarsus and the centre of the heel, identifies the medial part of the plantar fascia.
  • the second anatomical line of interest L2 passing between the base of the second metatarsus and the centre of the heel, allows identification of the longitudinal axis of the foot F'.
  • the third anatomical line of interest L3 passing between the base of the fifth metatarsus and the centre of the heel, identifies the lateral part of the plantar fascia.
  • a third degree curve CM is then constructed on said digital model 100 of the insole, passing through the three points that identify the base of the first, second and fifth metatarsus. These points are in fact the projection on the digital model 100 of the insole of the fundamental anatomical points PAF2, PAF3 and PAF4.
  • the support curve CM indicates the zone of contact of the metatarsal heads and is fundamental for defining the zone of contact of the foot with the ground, especially for the pushing phase, when the foot is about to detach from the ground.
  • the fundamental anatomical points PAF1-PAF4 can be projected directly onto the digital model 100 of the insole. In this way, the construction of the anatomical lines of interest L1-L3 and the corresponding support curve CM can be made on the digital model 100 on the basis of these projected points.
  • anatomical lines of interest L1-L3 can be defined directly on the reconstructed model of the foot F'; F" and then used to identify useful points P3-P5 on the digital model 100 of the insole, as illustrated below.
  • the positioning of the points PAF1 PAF2 PAF3 PAF4, the anatomical lines of interest L1 L2 L3 and the support curve CM defined can be automated by using machine learning trained on the basis of the datasets acquired according to the acquisition protocol described.
  • the anatomical areas of interest defined in this way are used during the 3D modelling step of the orthotic 1.
  • the anatomical lines of interest L1, L2 and L3, which identify the medial and lateral part of the plantar fascia, will be used to guarantee the necessary comfort for the foot F'.
  • an incorrect distribution of loads in the area of the plantar fascia could lead to severe pain and worsen the situation of the user.
  • the support curve CM of the metatarsal heads can, on the other hand, be used in the modelling method for the creation of design components of the orthotic insole 1, such as unloading zones, inserts for the creation of specific supports and adjustments necessary for the correct support of the foot.
  • the CAD modelling step shown in the drawings comprises the insertion of construction lines C1-C7 or construction curves C1-C7 perpendicularly to the longitudinal axis of the digital model 100 of the insole.
  • These lines C1-C7 are used for the three-dimensional modelling of the upper surface of the orthotic 1 (the one that will come into contact with the sole of the user's foot).
  • the construction curves C1-C7 are then positioned at specific points of the foot, which will be defined in more detail below.
  • construction curves C1-C7 advantageously offer greater control over the design parameters for the orthotic insole 1, whilst at the same time limiting the possibility of error when creating the upper surface of the orthotic insole 1 itself, compared to prior art models comprising a plurality of points arranged substantially in a grid-type fashion.
  • the insertion step of the construction curves C1-C7 can also be automated by using machine learning trained on the basis of the acquired datasets.
  • a first construction curve C1 is spaced from the most distal point 101 (rear portion 101) of the digital model 100 of the insole by a distance equal to about 5% of the total length of the insole itself.
  • This first construction curve C1 is used for the definition, on the digital model 100 of the orthotic, of the curvature of the heel area and for the definition, if necessary, of an enveloping and stabilising heel cup.
  • a second construction curve C2 is positioned at the point passing through the centre of the heel, that is, at the projection of said first fundamental anatomical point PAF1 on said digital model 100 of the insole. This point is usually located at between 5% and 15% of the length of the insole, that is, it is spaced from the rear 101 portion of the digital model 100 of the insole by a distance of between 5% and 15% of the total length of the insole.
  • the second construction curve C2 is used for the modelling of the heel zone and for the insertion of any structural modifications required on the digital model 100 of the orthotic, such as unloading areas, insertion of medial or lateral wedges, protrusions, etc.
  • a third construction curve C3 is positioned in the range of 15%-25% of the length of the insole, that is, it is spaced from the rear portion 101 of the digital model 100 of the insole by a distance of between 15% and 55% of the total length of the insole.
  • the third construction curve C3 identifies the proximal part of the calcaneus and the beginning of the next bone segment, and it is important for modelling the proximal part of the medial arch support on the digital model 100 of the orthotic.
  • a fourth construction curve C4 is positioned at the central point of the medial arch, about halfway between the point of contact of the heel (calcaneus) and the point of support of the first metatarsus, in the area of the joint between the navicular and cuneiform bones.
  • the fourth construction curve C4 allows the highest part of the medial arch to be modelled on the digital model 100 of the orthotic. The correct modelling of this area allows an orthotic to be created with the necessary support to make the insole effective during motor activities and to make the necessary corrections in case of pathological feet.
  • a fifth construction curve of C5 is positioned at the distal area of the first metatarsus.
  • the fifth construction curve C5 allows modelling of the curvature of the surface of the digital model 100 of the orthotic to match and accompany the end of the plantar arch as necessary.
  • a sixth construction curve C6 is positioned at the proximal phalanx, to adjust the height of the front zone on the digital model 100 of the orthotic and if necessary insert unloading points or phalanx supports.
  • a seventh construction curve C7 is placed on the front of the digital model 100 of the orthotic, to adjust the height of the area where the toes of the foot rest.
  • the support curve CM can be used for the correct positioning of the curves C6 and C7 in order to guarantee proper modelling, and any corrective changes, at the support zone, which often requires a support or an unloading point during modelling.
  • the sixth construction curve C6 and the seventh construction curve C7 can be positioned before and after the support curve CM, in such a way that the CM support curve is surrounded by these construction curves C6, C7 (as shown in Figure 8 ).
  • the respective distance between these construction curves C6 and C7 and the support curve CM can be approximately half the distance between the second fundamental anatomical point PAF2 and the third fundamental anatomical point PAF3, which varies from foot to foot. This distance is, in fact, an approximation of the radius of the first metatarsus.
  • construction lines C6 and C7 positioned in this way can also be moved manually by the technician on the basis of the reconstruction of the digital model of the foot F'; F" for any corrections or needs.
  • Figure 8 shows the construction curves C1-C7 just defined on a digital model of the orthotic, together with the anatomical lines of interest L1-L3 and the support curve CM.
  • Each of the seven construction curves C1-C7 is subsequently divided into six segments by means of seven points P1-P7.
  • the number of points P1-P7 has been studied in order to allow a simple, intuitive and uniform deformation of curves C1-C7 for the formation of the model of an orthotic insole 1, wherein the points P1-P7 can be inserted on the curves C1-C7 automatically.
  • a number of points P1-P7 other than seven may be used.
  • a number of points P1-P7 can be defined on the respective construction curve C1-C7 of less than seven, for example by imposing constraints on the tangents of these curves C1-C7.
  • Figure 9 shows the points P1-P7 on the construction curve C4. However, in the modelling step, these points P1-P7 are defined for each of the construction curves C1-C7.
  • points P1-P7 are used to modify the positions along the vertical axis z of the construction curves C1-C7, which are used as a structure (skeleton) to define the surfaces of the digital model 100 of the orthotic.
  • this machine-learning algorithm can be trained on the basis of the datasets acquired according to the acquisition protocol described, and in particular on the basis of the photographic images F1-F6, in such a way as to automatically assign the value of these positions, without the need for manual intervention by an operator.
  • first point P1 and the seventh point P7 are used to ensure contact between the construction curves C1-C7 and the external boundary of the digital model 100 of the orthotic.
  • These two points P1, P7 also lie, in fact, on the curve which outlines the boundary of the orthotic.
  • the second point P2 and the sixth point P6 are used to vary the starting curvature of the surface of the digital model 100 of the orthotic starting from the edge to ensure homogeneity and consistency.
  • the third point P3 and the fifth point P5 on the construction curves C2-C6 can be defined as the points of intersection with the respective anatomical lines of interest L1, L3, whilst on the first construction curve C1 and on the seventh construction curve C7, which do not intersect these anatomical lines of interest L1, L3, they can be defined as the points positioned at said predetermined distance from the longitudinal axis of the foot F'; F".
  • this predetermined distance can be estimated as half the distance between the longitudinal axis (that is, the axis passing through the second anatomical line of interest L2) and the outer edge of the digital model 100 of the orthotic.
  • this distance may vary in the order of 20% to meet any specific needs.
  • the third point P3 and the fifth point P5 can be used to define the positions along the vertical axis z of the surface of the digital model 100 of the orthotic at the anatomical areas of importance/interest, defined by the anatomical lines of interest L1, L3.
  • this area is one of the most sensitive areas at the orthotic level and, therefore, needs specific measures in the modelling phase. It is therefore advisable to ensure that any corrective or non-corrective changes to the orthotic 1 do not cause deformities in the areas of the plantar fascia.
  • Photos F1-F6 can be used to determine the optimum positions of these points P3, P5.
  • the fourth point P4 for the construction curves C2-C6 can be defined as the point of intersection with the second anatomical line of interest L2, whilst for the first construction curve C1 and for the seventh construction curve C7 the point P4 can be defined as the point on the longitudinal axis of the foot F'; F".
  • This fourth point P4 serves to vary the position, along the vertical axis z, of the respective construction curve, in the zone corresponding to the longitudinal axis of the foot F'. Again, photos F1-F6 can be used to determine the optimum positions of this fourth point P4.
  • points P1-P7 and of the construction lines C1-C7 may involve the use of clinical data, such as baropodometric data, force distribution, centre of mass position, MRI, CT, gait analysis.
  • clinical data such as baropodometric data, force distribution, centre of mass position, MRI, CT, gait analysis.
  • This allows specific modifications to be made which reflect the deformities and/or needs derived from the medical analysis.
  • it is possible to integrate the results of the baropodometric examinations to optimise the redistribution of the pressures and plantar forces during the walking phases.
  • diagnostic imaging data can be used to position unloading points or structural changes in the orthotic 1 for specific needs such as, for example, a support to prevent structural collapse of the plantar joints, as in the case of flatfoot, or as in the case of pain associated with deformities such as, for example, pain associated with foot spur.
  • the upper surface of the digital model 100 of the orthotic 1 is then generated started from the construction curves C1-C7 thus defined and controlled in terms of curvature and homogeneity.
  • the external boundary of the digital model 100 of the insole can be projected onto the horizontal plane tangential to the lower surface of the digital model 100 itself.
  • This closed curve can be subsequently modified to allow the orthotic to adapt to the reference footwear and to take into account the necessary differences between the upper and lower surface of orthotic 1, in order to guarantee the necessary mechanical response for the user's needs.
  • the difference between the upper and lower surface at the medial arch guarantees a better elastic behaviour and at the same time increases the wearability and comfort level of the orthotic inside the footwear.
  • the orthotic 1 can be obtained from the Boolean sum of the described surfaces.
  • a trained operator/algorithm can select the final thickness of the digital model 100 of the orthotic insole 1, based on the material with which the physical model will then be made.
  • the implemented method is not bound to the use of a single predefined material, but can be adapted to the use of materials with different mechanical properties and different mechanical responses under stress.
  • any further modifications can be made to the final digital model 100 of the orthotic 1, which are necessary to increase the therapeutic or performance effectiveness of the orthotic 1, such as the insertion of back supports at the level of the metatarsal heads, designed to redistribute the forces and obtain an anatomical curvature of the transversal arch. It is also possible to create flarings or housings to reduce locally the pressures and recreate anatomical physiological curvatures at the level of the metatarsal heads. Additionally, specific supports can be inserted in areas of interest, such as individual metatarsal support bars or medial or lateral arch support bars. Finally, wedges necessary for a rotation of the foot at the front, back or both can be inserted to realign the joints in a physiological manner.
  • Figure 12 shows some of the zones that can be modified on a digital model 100 of the orthotic 1.
  • an orthotic insole 1 starting from the digital model 100 obtained by means of 3D printing, for example by optimising one or more of the following 3D printing production parameters:
  • the digital model 100 of the orthotic 1 developed consists of several zones directly defined on the basis of the anatomy of the foot F' or F' and the data provided, these zones can be differentiated in terms of mechanical response by modifying the production parameters.
  • the extrusion flow the printing speed (that is, extruder movement speed), the use of material with a hardness index (Shore) between A70 and A95 can be varied to differentiate this mechanical response.
  • the printing speed that is, extruder movement speed
  • the use of material with a hardness index (Shore) between A70 and A95 can be varied to differentiate this mechanical response.
  • zones can be defined with a lower density or with different infill geometries (e.g. honeycomb, gyroid, rectangular) to guarantee a different stiffness of the structure (with a consequent redistribution of the pressures on the foot) and a different mechanical response.
  • infill geometries e.g. honeycomb, gyroid, rectangular
  • the disclosure relates to a method for the production of a customised corrective and/or sports orthotic insole 1 which comprises:
  • the method may comprise the acquisition of two videos (one for each foot) according to the protocol established and detailed in the description.
  • the method may provide for specific positioning of the foot F' or F' and of the acquisition device C in order to comply with instructions I1 to I10.
  • the videos acquired can in fact constitute a fundamental part of the dataset for the production of the orthotic insole 1 according to the method of the invention.
  • the method according to the disclosure may also comprise the acquisition of a total of six photos according to the protocol described. More in detail, the method may comprise acquiring the photos F1-F6 following the instructions described, creating a photographic database for the production of the orthotic insole.
  • the method according to the invention may comprise the use of special clothing (that is, socks, stockings, bands, meshes).
  • the method according to the disclosure may also comprise the definition of the fundamental anatomical points PAF1 PAF2 PAF3 PAF4 and the anatomical lines L1 L2 L3 CM as defined above.
  • the procedure for positioning the points PAF1 PAF2 PAF3 PAF4 and the anatomical lines L1 L2 L3 CM can be carried out using machine learning trained on the basis of the datasets acquired exclusively according to the acquisition protocol defined above.
  • the method according to the disclosure may comprise the definition of the curves C1 to C7 of the points P1 to P7 identified in the description.
  • the method according to the disclosure may comprise modifying the coordinates of the points P1-P7 and the construction parameters of the curves C1-C7 in a range of 10% with respect to what is described.
  • the method according to the disclosure can comprise the optimisation of production parameters through 3D printing such as:
  • the method according to the disclosure can integrate clinical data such as, by way of example only and certainly not exhaustive, baropodometric data, force distribution, centre of mass position, MRI, CT, gait analysis.

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Claims (15)

  1. Verfahren zur Herstellung einer individuell angepassten korrigierenden und/oder sportorthopädischen Einlage (1) für einen Fuß (F', F") eines Benutzers, umfassend die folgenden Schritte:
    A. Erfassen eines Datensatzes, umfassend fotografische Bilder des Fußes (F'; F") und ein rekonstruiertes Modell des Fußes (F'; F"), wobei das rekonstruierte Modell des Fußes (F'; F") ein dreidimensionales digitales Modell des Fußes (F'; F") ist; und
    B. Konstruieren und Modellieren, mittels CAD-Modellierung, der korrigierenden und/oder sportorthopädischen Einlegesohle (1) anhand des rekonstruierten Modells des Fußes (F'; F"), aus dem Datensatz, umfassend fotografische Bilder des Fußes (F'; F"), und aus einem digitalen Modell (100) der Einlegesohle eines Referenzschuhs, wobei das CAD-Modellieren die folgenden Teilschritte umfasst:
    B1. Bemessen des digitalen Modells (100) der Einlegesohle basierend auf den Abmessungen des Fußes (F', F");
    B2. Identifizieren auf dem rekonstruierten Modell des Fußes (F'; F") von vordefinierten grundlegenden anatomischen Punkten (PAF1-PAF4), wobei ein erster grundlegender anatomischer Punkt (PAF1) die Mitte der Ferse ist,
    ein zweiter grundlegender anatomischer Punkt (PAF2) die Basis des ersten Mittelfußes ist,
    ein dritter grundlegender anatomischer Punkt (PAF3) die Basis des zweiten Mittelfußes ist, und
    ein vierter grundlegender anatomischer Punkt (PAF4) die Basis des fünften Mittelfußes ist;
    B3. Positionieren des rekonstruierten Modells des Fußes (F'; F") in einer neutralen Position in Bezug auf die äußere Abgrenzung des digitalen Modells (100) der bemessenen Einlegesohle, wobei der erste fundamentale anatomische Punkt (PAF1), der zweite fundamentale anatomische Punkt (PAF2) und der vierte fundamentale anatomische Punkt (PAF4) auf einer gleichen Ebene liegen;
    B4. nach dem Positionieren des rekonstruierten Modells des Fußes (F'; F") in einer neutralen Position, Drehen und Neigen des rekonstruierten Modells des Fußes (F'; F"), insbesondere um es in einer Position zu positionieren, die für einen vordefinierten Korrekturbedarf geeignet ist;
    B5. nach der Drehung und Neigung des rekonstruierten Modells des Fußes (F'; F"), Definieren von drei anatomischen Linien von Interesse (L1- L3) auf dem digitalen Modell (100) der Einlegesohle, wobei
    eine erste anatomische Linie von Interesse (L1) sich auf die Linie bezieht, die zwischen der Basis des ersten Mittelfußes und der Mitte der Ferse des rekonstruierten Modells des Fußes (F'; F") verläuft, um den medialen Teil der Plantarfaszie zu identifizieren,
    eine zweite anatomische Linie von Interesse (L2) in Bezug auf die Linie, die zwischen der Basis des zweiten Mittelfußes und der Mitte der Ferse verläuft, um die Längsachse des Fußes zu identifizieren, und
    eine dritte anatomische Linie von Interesse (L3) sich auf die Linie bezieht, die zwischen der Basis des fünften Mittelfußes und der Mitte der Ferse verläuft, um den seitlichen Teil der Plantarfaszie zu identifizieren;
    B6. Erstellen einer Vielzahl von Erstellungskurven (C1-C7) auf dem digitalen Modell (100) der Einlegesohle, die im Wesentlichen senkrecht zu der zweiten anatomischen Linie von Interesse (L2) verlaufen, zum dreidimensionalen Modellieren der oberen Fläche der orthopädischen Einlegesohle (1);
    B7. Definieren von mindestens drei Punkten (P3-P5) auf jeder der Erstellungskurven (C1-C7) in Übereinstimmung mit den anatomischen Linien von Interesse (L1-L3) oder in einem vorbestimmten Abstand von der Längsachse des Fußes (F'; F"), die mittels der zweiten anatomischen Linien von Interesse (L2) identifiziert wird; und
    B8. Verwenden des Datensatzes, umfassend fotografische Bilder des Fußes (F'; F"), um die Positionen der drei Punkte (P3-P5) entlang einer vertikalen Achse (2) zu modifizieren, um die Geometrie der oberen Fläche der orthopädischen Einlegesohle (1) zu modellieren.
  2. Verfahren nach Anspruch 1, dadurch gekennzeichnet, dass in dem Teilschritt B5 auch eine Stützkurve (CM) auf dem digitalen Modell (100) erstellt wird, wobei die Stützkurve (CM) mit einer Kurve dritten Grads angenähert wird, die durch drei Punkte in Bezug auf die Basis des ersten, zweiten und fünften Mittelfußknochens verläuft, auf eine Weise, um den Kontaktbereich der Mittelfußköpfe anzugeben und der Kontaktbereich des Fußes während der Schubphase mit dem Boden identifiziert wird, wenn der Fuß dabei ist, sich vom Boden zu lösen.
  3. Verfahren nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass in dem Teilschritt B6 sieben Erstellungskurven (C1-C7) an dem digitalen Modell (100) der Einlegesohle erstellt werden, wobei eine erste Erstellungskurve (C1) von dem hinteren Abschnitt (101) des digitalen Modells (100) der Einlegesohle um einen Abstand von 5 % der Gesamtlänge der Einlegesohle beabstandet ist, um die Krümmung des Bereichs der Ferse des Fußes (F') auf der Oberseite der orthopädischen Einlegesohle (1) zu definieren;
    eine zweite Erstellungskurve (C2) an der Projektion des ersten grundlegenden anatomischen Punkts (PAF1) des rekonstruierten Modells des Fußes (F'; F") auf dem digitalen Modell (100) der Einlegesohle positioniert ist, auf eine Weise, um den Bereich der Ferse des Fußes (F'; F") auf der oberen Fläche der orthopädischen Einlegesohle (1) zu definieren;
    eine dritte Erstellungskurve (C3) von dem hinteren Abschnitt (101) des digitalen Modells (100) der Einlegesohle um einen Abstand zwischen 15 % und 25 % der Gesamtlänge der Einlegesohle beabstandet ist, auf eine Weise, um den proximalen Teil der medialen Fußgewölbestütze (F'; F") auf der oberen Oberfläche der orthopädischen Einlegesohle (1) zu modellieren; eine vierte Erstellungskurve (C4) an dem mittleren Punkt des Mittelfußgewölbes, etwa auf halbem Weg zwischen dem Kontaktpunkt der Ferse und dem Stützpunkt des ersten Mittelfußes, im Bereich des Gelenks zwischen dem Kahnbein und dem Keilbein, positioniert ist, auf eine Weise, um die Modellierung des höchsten Teils des Mittelfußgewölbes für den Fuß (F'; F") auf der Oberfläche der orthopädischen Einlegesohle (1) zu ermöglichen;
    eine fünfte Erstellungskurve (C5) in dem distalen Bereich des ersten Mittelfußes positioniert ist, auf eine Weise, um in der Lage zu sein, die Krümmung der oberen Oberfläche der orthopädischen Einlegesohle (1) zu optimieren;
    eine sechste Erstellungskurve (C6) an der proximalen Phalanx positioniert ist, auf eine Weise, um die Höhe des vorderen Bereichs der oberen Oberfläche der orthopädischen Einlegesohle (1) einzustellen; und
    eine siebte Erstellungskurve (C7) auf dem vorderen Abschnitt des digitalen Modells (100) der Einlegesohle positioniert ist, um die Höhe des Bereichs einzustellen, wo die Zehen des Fußes (F'; F") auf der oberen Oberfläche der orthopädischen Einlegesohle (1) aufliegen.
  4. Verfahren nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass in dem Teilschritt B7 für jede der Erstellungskurven (C1-C7) sieben Punkte (P1-P7) definiert werden, wobei ein erster Punkt (P1) und ein siebter Punkt (P7) der sieben Punkte (P1-P7) die Endpunkte (P1, P7) sind und auf dem äußeren Rand des digitalen Modells (100) der Einlegesohle liegen;
    ein zweiter Punkt (P2) und ein sechster Punkt (P6) der sieben Punkte (P1-P7) in einem Abstand zwischen 1 mm und 3 mm von der Außenkante des digitalen Modells (100) der Einlegesohle platziert sind; und
    ein dritter Punkt (P3), ein vierter Punkt (P4) und ein fünfter Punkt (P5) die drei Punkte (P3-P5) sind;
    wobei während des Teilschritts B8 die Positionen des ersten Punkts (P1), des zweiten Punkts (P2), des sechsten Punkts (P6) und des siebten Punkts (P7) entlang der vertikalen Achse (z) modifiziert werden, um die obere Oberfläche der orthopädischen Einlage (1) zu modellieren.
  5. Verfahren nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass während des Schritts B. die äußere Abgrenzung des digitalen Modells (100) der Einlegesohle auf eine horizontale Ebene projiziert wird, die tangential zu der unteren Oberfläche des digitalen Modells (100) verläuft, wobei die Projektion der äußeren Begrenzung anschließend modifiziert wird, um die Anpassung der hergestellten orthopädischen Einlegesohle (1) an das Referenzschuhwerk zu ermöglichen.
  6. Verfahren nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass der im Schritt A. erfasste Datensatz sechs fotografische Bilder (F1-F6) umfasst, die mittels einer Erfassungsvorrichtung (C) erfasst werden, die mit einem Objektiv ausgestattet ist, durch die folgenden Teilschritte:
    A1. Erfassen, mittels der Erfassungsvorrichtung (C), eines ersten fotografischen Bilds (F1) des Fußgewölbes des rechten Fußes (F'), wobei das erste fotografische Bild (F1) erfasst wird, nachdem der rechte Fuß (F') auf einer Kante eines A4-Blatts positioniert wurde, wobei die Auflagepunkte der jeweiligen Ferse und des Mittelfußes tangential zu der Kante liegen und der linke Fuß (F") angehoben gehalten wird, wobei die Erfassungsvorrichtung (C) vor dem Schienbeinknöchel des rechten Fußes (F') platziert ist und während der Erfassung auf der gleichen Höhe wie der Knöchel gehalten wird;
    A2. Erfassen, mittels der Erfassungsvorrichtung (C), eines zweiten fotografischen Bilds (F2) des Fußgewölbes des linken Fußes (F'), wobei das zweite fotografische Bild (F2) erfasst wird, nachdem der linke Fuß (F") auf einer Kante eines A4-Blatts positioniert wurde, wobei die Auflagepunkte der jeweiligen Ferse und des Mittelfußes tangential zu der Kante liegen und der linke Fuß (F") angehoben gehalten wird, wobei die Erfassungsvorrichtung (C) vor dem Schienbeinknöchel des linken Fußes (F") platziert ist und während der Erfassung auf der gleichen Höhe wie der Knöchel gehalten wird;
    A3. Erfassen, mittels der Erfassungsvorrichtung (C), eines dritten fotografischen Bilds (F3) des rechten Fußes (F') unter Belastung, wobei der rechte Fuß (F') auf die jeweilige Zehe drückt und die Ferse wie beim Gehen angehoben ist, wobei der linke Fuß (F") vor dem rechten Fuß (F') platziert ist, wobei die Erfassungsvorrichtung (C) vor dem Schienbeinknöchel platziert ist und während der Erfassung auf der gleichen Höhe wie der Knöchel gehalten wird;
    A4. Erfassen, mittels der Erfassungsvorrichtung (C), eines vierten fotografischen Bilds (F4) des linken Fußes (F") unter Belastung, wobei der rechte Fuß (F') auf die jeweilige Zehe drückt und die Ferse wie beim Gehen angehoben ist, wobei der linke Fuß (F") vor dem rechten Fuß (F') platziert ist, wobei die Erfassungsvorrichtung (C) vor dem Schienbeinknöchel platziert ist und während der Erfassung auf der gleichen Höhe wie der Knöchel gehalten wird;
    A5. Erfassen, mittels der Erfassungsvorrichtung (C), eines fünften fotografischen Bilds (F5) der Füße (F', F") mit verbundenen Fersen, wobei beide Füße (F', F") mit verbundenen Fersen positioniert sind und die Zehen getrennt sind, um einen 90 °-Winkel in Bezug auf die Verbindung der Fersen zu bilden, wobei die Erfassungsvorrichtung (C) vor den Füßen (F', F") platziert ist, auf eine Weise, um die zwei medialen Bereiche der jeweiligen Füße einzurahmen und während der Erfassung auf der gleichen Höhe wie die Knöchel gehalten wird; und
    A6. Erfassen, mittels der Erfassungsvorrichtung (C), eines sechsten fotografischen Bilds (F6) der Fersen der beiden Füße (F', F") wobei die Füße (F', F") in Höhe des Gelenks ihrer jeweiligen Hüften beabstandet sind, wobei die Erfassungsvorrichtung (C) vor den Fersen der Füße (F', F") platziert und auf der gleichen Höhe wie der Ansatz der Achillessehne an der Ferse der Füße (F', F") gehalten wird.
  7. Verfahren nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass die Punkte (PAF1-PAF3, P1-P7), die Linien (L1-L3) und die Kurven (CM; C1-C7), die während des Schritts B. verwendet werden, unter Verwendung eines Algorithmus für maschinelles Lernen berechnet werden, der basierend auf dem Datensatz trainiert wird, der fotografische Bilder des Fußes (F'; F") umfasst, die in dem Schritt A. erfasst werden.
  8. Verfahren nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass das rekonstruierte Modell des Fußes (F'; F") anhand einer Vielzahl von Frames eines Videos des Fußes (F'; F") rekonstruiert wird, wobei die Erfassung eines Videos für jeden Fuß (F'; F") mittels der Erfassungsvorrichtung (C) gemäß den folgenden Anweisungen ausgeführt wird:
    I1. den Benutzer veranlassen, ein Bein (L) auszustrecken, es auf eine Stütze (R) aufzulegen, auf eine Weise, dass das Bein (L) parallel zu dem Boden ist;
    I2. den Fuß (F'; F") in Bezug auf das Bein aus der Stütze (R) hervorstehen zu lassen, auf eine Weise, dass der Fuß (F'; F") ab dem Knöchel hängend ist;
    I3. den Fuß (F'; F") in der relativen Sagittalebene und Plantarebene senkrecht zu der Längsachse des Beins halten;
    I4. die Zehen des Fußes (F'; F") aktiv und maximal strecken;
    I5. ein Video des Fußes (F'; F") mittels der Erfassungsvorrichtung (C) erfassen, wobei die Erfassungsvorrichtung (C) um den Fuß gedreht wird, auf eine Weise, dass die Erfassungsvorrichtung (C) immer innerhalb eines vordefinierten Überlappungsbereichs bleibt,
    wobei die Anweisung I5 durch Drehen der Erfassungsvorrichtung (C) um den Fuß mit einer Drehung zwischen 200° und 300° und einer konstanten Bewegungsgeschwindigkeit von etwa 7,5 Grad/Sek. ausgeführt wird, wobei die Linse der Erfassungsvorrichtung (C) in einem Abstand von einem Meter von dem Fuß (F'; F") gehalten wird, wobei die Linse in der gleichen Höhe wie der Fuß (F'; F") in Bezug auf den Boden platziert ist, und wobei ein Positionieren von reflektierenden Oberflächen in dem Erfassungsbereich und eine Aussetzung an direkte Lichtquellen vermieden wird.
  9. Verfahren nach Anspruch 8, wobei die Vielzahl von Frames anhand eines Videos eines jeweiligen Fußes (F'; F") extrahiert wird, wobei 80 % des Bilds eines Frames in Bezug auf einen Bereich des gefilmten Raums auf einem nachfolgenden Frame überlagert ist,
    wobei das rekonstruierte Modell des Fußes (F'; F") in Form einer CAD-Datei vom Typ Mesh anhand der Vielzahl von Frames erlangt wird.
  10. Verfahren nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass klinische Daten des Benutzers in den Schritt B. integriert werden, insbesondere baropodometrische Daten, Kraftverteilung, Position des Massenschwerpunkts, MRI, CT, Ganganalyse.
  11. Verfahren nach einem der vorherigen Ansprüche, dadurch gekennzeichnet, dass der Schritt A. mittels eines mobilen Erfassungsgeräts, insbesondere eines Smartphones oder Tablets, ausgeführt wird, das konfiguriert ist, um den Datensatz zu erfassen, umfassend fotografische Bilder des Fußes (F'; F") und ein rekonstruiertes Modell des Fußes (F'; F"), und an eine entfernte Server-Steuereinheit sendet, und dass der Schritt B. mittels der entfernten Server-Steuereinheit ausgeführt wird.
  12. System, umfassend Einrichtungen, die für die Ausführung der Schritte eines Verfahrens nach einem der vorherigen Ansprüche konfiguriert sind.
  13. System nach Anspruch 12, dadurch gekennzeichnet, dass es eine mobile Erfassungsvorrichtung und eine Steuereinheit eines entfernten Servers umfasst, wobei die mobile Erfassungsvorrichtung konfiguriert ist, um den Datensatz zu erfassen, der fotografische Bilder des Fußes (F'; F") und ein rekonstruiertes Modell des Fußes (F'; F") umfasst, und an die Steuereinheit des entfernten Servers zu senden, und wobei die Steuereinheit konfiguriert ist, um den Schritt B auszuführen.
  14. Computerprogramm, umfassend Anweisungen, sodass sie, wenn das Programm von einem System nach Anspruch 12 oder 13 ausgeführt wird, die Ausführung der Schritte eines Verfahrens nach einem der Ansprüche 1 bis 11 mittels des Systems bewirken.
  15. Datenträgersignal, das die Anweisungen eines Programms nach Anspruch 14 trägt.
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